Study of SKB264 for Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer

NCT06081959 | Recruiting Phase 3 DMC

• 1 other identifier: SKB264-Ⅲ-10
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of SKB264 in patients with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS) assessed by BIRC per RECIST 1.1.

  PFS, defined as the time from randomization to PD or death, whichever occurs first.

  up to 24 months

Secondary Outcomes (7)

• Overall Survival (OS)

  up to 24 months

• Progression-free survival (PFS) assessed by the investigators per RECIST V 1.1

  up to 24 months

• Objective Response Rate (ORR)

  up to 24 months

• Disease Control Rate (DCR)

  up to 24 months

• Duration of Response (DoR)

  up to 24 months

Study Arms (2)

SKB264 for injection

EXPERIMENTAL

Drug: SKB264

Treatment of Physician's Choice

ACTIVE COMPARATOR

Eribulin, capecitabine, gemcitabine or vinorelbine will be administered and managed according to the investigator's clinical judgment, guided by clinical practice.

Drug: Eribulin; Drug: Capecitabine; Drug: Gemcitabine; Drug: Vinorelbine

Interventions

SKB264 DRUG

IV infusion on day 1 and Day 15 of each 28 day cycle

SKB264 for injection

Eribulin DRUG

1.4 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle

Treatment of Physician's Choice

Capecitabine DRUG

1000-1250 mg/m2, po, bid, from day 1 to Day 15 of each 21 day cycle

Treatment of Physician's Choice

Gemcitabine DRUG

1000 mg/m2, IV infusion on day 1 and Day 8 of each 21day cycle

Treatment of Physician's Choice

Vinorelbine DRUG

25 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle

Treatment of Physician's Choice

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females aged ≥ 18 to ≤ 75 years at the time of signing the ICF;
• Histologically and/or cytologically confirmed HR+/HER2- breast cancer based on pathology reports on recent biopsy specimens or other pathological samples;
• Patients who had failed at least one line of systemic chemotherapy in unresectable locally advanced, recurrent, or metastatic stage;
• Patients with at least one measurable lesion per RECIST 1.1 criteria; those with only skin or bone lesions cannot be included;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
• Expected survival ≥ 12 weeks;
• Adequate organ and bone marrow function;
• Patients who are eligible for a chemotherapy regimen in the control group;
• Female patients of childbearing potential and male patients with partners of childbearing potential who use effective medical contraception from the time of signing the informed consent form until 6 months after the last dose;
• Patients who voluntarily participate in the study and sign the ICF, and able to comply with the visit and related procedures stipulated in the plan.

You may not qualify if:

• Patients with a history of central nervous system (CNS) metastases or current CNS metastases；
• Patients with other malignancies (except cured basal or squamous cell skin cancer or carcinoma in situ of the cervix) within 3 years prior to the first dose;
• Patients with any cardio cerebral Vascular disease or cardio cerebral vascular risk factors may affect investigational treatment;
• Uncontrollable systemic diseases assessed by the investigator;
• History of (noninfectious) interstitial lung disease (ILD)/noninfectious neumonitis requiring steroid therapy and current ILD/noninfectious pneumonitis, or ILD/noninfectious pneumonitis at screening that cannot be excluded by imaging;
• Clinically serious lung injuries caused by lung diseases;
• Patients with active chronic Inflammatory bowel disease, gastrointestinal obstruction, severe ulcer, gastrointestinal perforation, abdominal abscess or acute gastrointestinal bleeding;
• Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1;
• Active hepatitis B or hepatitis C;
• Human immunodeficiency virus (HIV) antibody test positive or a history of acquired immunodeficiency syndrome (AIDS), known active syphilis infection;
• Known allergy or hypersensitivity to SKB264, or the excipients of SKB264;
• Prior TROP2 targeted therapy, prior topoisomerase I inhibitor therapy, including antibody-drugconjugate(ADC) therapy;
• Patients who received major surgeries 4 weeks prior to the first dose of study treatment or planned to receive major surgeries during the study ;
• Patients with concomitant infections requiring systemic antibiotic therapy within 2 week prior to the first dose of study treatment;
• Patients who have received live vaccines within 30 days prior to the first dose, or are scheduled to receive live vaccines during the study;

Sponsors & Collaborators

• Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Science

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

eribulin; Capecitabine; Gemcitabine; Vinorelbine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Central Study Contacts

Yina Diao

CONTACT

86-13402828610; diaoyina@kelun.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2023
• First Posted: October 13, 2023
• Study Start: October 31, 2023
• Primary Completion: March 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

CN (1)